Clinic for Child and Adolescence Psychiatry, Neurology, Psychosomatics and Psychotherapy, University of Rostock, -Rostock, Germany.
Bayer Vital GmbH, Leverkusen, Germany.
Pharmacopsychiatry. 2014 Jan;47(1):29-32. doi: 10.1055/s-0033-1361115. Epub 2013 Dec 4.
The trial was a double-blind, placebo-controlled comparison with a discontinuation design. 49 mentally retarded patients with aggressive behaviour were treated with zuclopenthixol at a dose of 2-20 mg/d. At each visit the clinical effect was evaluated. Correlations between dose, serum concentration, and efficacy measures were calculated. The mean dose was 10.0 mg/day (±5.17); the mean serum concentration 4.19 ng/mL (±3.16). Associations of dosage, serum concentration and clinical efficiency did not result in coherent patterns. Correlations with clinical efficiency measures appeared to be contradictory for dosage and serum concentrations, respectively. As no consistent associations between dosage, serum concentration, and clinical efficiency measures were found, different hypotheses explaining the results are discussed.
该试验采用双盲、安慰剂对照、停药设计。49 名具有攻击性行为的智障患者接受了剂量为 2-20mg/d 的氯氮平治疗。每次就诊时都评估临床效果。计算了剂量、血清浓度和疗效指标之间的相关性。平均剂量为 10.0mg/天（±5.17）；平均血清浓度为 4.19ng/mL（±3.16）。剂量、血清浓度和临床疗效之间的关联没有形成一致的模式。剂量和血清浓度与临床疗效指标的相关性分别存在矛盾。由于未发现剂量、血清浓度和临床疗效指标之间存在一致的关联，因此讨论了不同的假设来解释结果。
